Cleared Traditional

K141460 - FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR

K141460 is an FDA 510(k) clearance for FINAPRES NOVA NONINVASIVE HEMODYNAMIC M..., manufactured by Finapres Medical Systems B.V.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K141460 · Finapres Medical Systems B.V. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
291d
Days
Class 2
Risk

K141460 is an FDA 510(k) clearance for the FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Finapres Medical Systems B.V. (Amsterdam, NL). The FDA issued a Cleared decision on March 20, 2015 after a review of 291 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Finapres Medical Systems B.V. devices

FDA 510(k) Submission Details - K141460

510(k) Number K141460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2014
Decision Date March 20, 2015
Days to Decision 291 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 125d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 844
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K141460.
Digital Automatic Wrist Blood Pressure Monitor MD2400
K143733 · Grandway Technology (Shenzhen) Limited · Apr 2015
Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)
K150545 · Sejoy Electronics & Instruments Co., Ltd. · Apr 2015
HealthGuard-15
K143108 · Futrex, Inc. · Mar 2015
Full Automatic (NIBP) Blood Pressure Monitor
K142968 · Health & Life Co., Ltd. · Dec 2014
BP652N (HEM-6300-Z)
K142917 · Omron Healthcare, Inc. · Dec 2014
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K133989 · Mortara Instrument, Inc. · Nov 2014